Rep. Henry Waxman, Senators Charles Schumer, and Hillary Clinton, along with House Members Jo Ann Emerson and Frank Pallone, introduced the “Access to Life-Saving Medicine Act,” which will give Food and Drug Administration the express legal authority to approve safe, lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals.

Biotech drugs, which are produced from living cell cultures rather than being synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill.  Currently there is no statutory pathway for generic versions of biotech drugs to enter the market, even after all patents have expired.

As a result, the manufacturers of biotech drugs can charge monopoly prices, indefinitely.  In addition to the other members, Senators David Vitter, Debbie Stabenow, Patrick Leahy, Susan Collins and Representative Rahm Emanuel are original cosponsors of the legislation.

This bill comes in response to years of recognition of the need for a new statutory pathway for approval of generic versions of biotech drugs.  These products are not subject to the 1984 law that first authorized FDA to approve generic drugs.  The EMEA, which is Europe’s equivalent of the FDA, has had a legal framework in place for approval of “biosimilars” since 2004.  In letters received recently, both the AARP and the Coalition for a Competitive Pharmaceutical Market — composed of employers, health plans, generic drug companies, pharmacy benefit managers, and pharmacists — agree that legislation creating a pathway for approval of generic biologics is critically important to assure access to more affordable drugs.